An Integrated Pediatric Clinical Research and Health Care System

Cook Children’s Health Care System, located in Fort Worth, Texas, operates a pediatric clinical research program with unlimited potential for sponsored investigations.  We are actively enrolling pediatric subjects in more than 200 clinical trials across most pediatric therapeutic areas.  Nearly one million patient visits to Cook Children's facilities occur each year.

Cook Children's Medical Center, our central facility, is located about 40 minutes from the DFW International Airport:

• 285-bed, free-standing pediatric hospital
•  the only tertiary care children's hospital between Fort Worth and New Mexico (an area of more than 100,000 square miles)
• accredited by the Joint Commission on the Accreditation of Healthcare Organizations
• medical staff of approximately 500 pediatricians, pediatric sub-specialists, surgeons, family practitioners, and dentists
• 30 pediatric services and specialties for children and young adults from birth to 18 years, including nationally recognized programs for neonatology, hematology/oncology, bone marrow transplant, cardiology and cardiothoracic surgery, neurology and neurosurgery, and pulmonology.
• Level 4 Pediatric Epilepsy Program

Cook Children's clinics are present throughout the Dallas-Fort Worth metropolitan area:

• over 100 Pediatric Primary Care Pediatricians operating practices in over 30 regional offices
• two Urgent Care centers 
• four Neighborhood Clinics in underserved neighborhoods. \
• wide array of specialty clinics located in rural or underserved Texas communities.    

A network of physician investigators

Cook Children’s Physician Network is the largest pediatric multi-specialty physician group in Texas. The company is comprised of 226 physicians providing medical and surgical care in 58 primary care pediatric and pediatric subspecialty practices located primarily in the greater Fort Worth metropolitan area and surrounding communities. Our physicians are active or potentially active investigators during all phases of pharmaceutical product, medical device or therapeutics development.

A Research Administration Office to Coordinate Every Project

All clinical research activity is centralized through the Cook Children’s  Research Administration Office.  Every physician may be an investigator.  Every patient visit represents an opportunity for clinical trial enrollment.

The Office efficiently manages all phases of each project.  Investigators and staff are provided with ongoing training, support and oversight to assure compliance with regulatory agencies and good clinical practices.  A flexible pool of clinical research coordinators serves the investigators individually or, in some cases, by clinical department. 

 Research services include:

• efficient study placement to match projects with potential investigators
• in-depth feasibility analysis
• review and negotiation of Confidential Disclosure and Clinical Trial Agreements
• review and negotiation of trial budgets
• preparation & submission of IRB documents
• assistance with recruitment of study patients
• accounting and financial management
• completion of protocol requirements as delegated by the investigator
• data and document management through trial close-out and storage

Interested Sponsors may contact an Investigator or the Cook Children's Research Administration Office.

Institutional Review Board (IRB)

Cook Children's Health Care System requires that all research protocols conducted at Cook Children's receive approval by our  Institutional Review Board, which meets twice each month.

Dedicated Research Administration Leaders



James Marshall, MD, FAAP
Medical Director of Clinical Research

Pediatric Intensive Care and Clinical Pharmacology
Phone: 682-885-3643
jmarshall@cookchildrens.org



Leigh Donahue, RN, MBA, CCRC
Director, Research Operations
Phone: 682-885-7491
LeighD@cookchildrens.org